[Comparison and application of direct and indirect methods in establishing reference intervals for coagulation tests]

Area of Science:

• Clinical Chemistry
• Hematology
• Medical Diagnostics

Background:

• Establishing accurate reference intervals is crucial for interpreting coagulation test results.
• Automated coagulation analyzers require validated, localized reference intervals for optimal clinical use.
• Direct and indirect methods offer different approaches to determining these intervals.

Purpose of the Study:

• To establish adult reference intervals for coagulation parameters (APTT, PT, TT, Fib) using the CN-6000 analyzer.
• To compare the applicability of direct and indirect methods for determining these intervals across different populations.
• To evaluate the performance of both methods in healthy, relatively healthy, and diseased patient groups.

Main Methods:

• A cross-sectional and retrospective study design was employed.
• The direct method involved testing coagulation parameters in adult participants (18-64 and ≥65 years).
• The indirect method utilized the refineR algorithm on existing coagulation data from non-ICU patients.

Main Results:

• Localized reference intervals were established for APTT, PT, TT, and Fib using the CN-6000 analyzer.
• The direct and indirect methods produced comparable results in healthy and relatively healthy individuals.
• Significant differences were observed between the methods in patients with high disease prevalence, particularly for Fib.

Conclusions:

• Localized reference intervals for the CN-6000 analyzer were successfully established.
• The indirect method is a suitable alternative to the direct method for healthy and relatively healthy populations.
• The indirect method's utility is limited in populations with high disease prevalence, necessitating careful clinical interpretation.